UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Single center, double-blind, randomized, parallel trial to evaluate the efficacy of rhizopus koji extract containing food in subjects with menopause symptom
Title of the study (Brief title)	Evaluation study of the efficacy for menopause symptom
Region	Japan

Condition
Condition	menopause symptom
Classification by specialty	Medicine in general Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of rhizopus koji extract containing food in improving menopause symptom after 4-week intake
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Kupffer man menopausal index ( Abe modification)
Key secondary outcomes	SDS,STAI

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	rhizopus koji extract containing food
Interventions/Control_2	Placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	45 years-old <=
Age-upper limit	60 years-old >
Gender	Female
Key inclusion criteria	(1)Japanese female ages 45-59 years old (inclusive) (2)Subjects with Kupffer man menopausal index more than 23 scores (3)Willing and able to provide signed written informed consent
Key exclusion criteria	(1)Subjects with severe hepatic, renal, cardiac, gastrointestinal, hematologic, endocrine and metabolic diseases / disorders (2)Subjects with history of sensitivity to the ingredients (3)Subjects who had participated in other clinical trials including drug and food within 1 month. (4)Pregnant, lactating women or willing to be pregnancy during the study (5)Any candidate considered to be unsuitable for enrollment in the opinion of the principal investigator
Target sample size	20

Research contact person
Name of lead principal investigator	Masaki Nishiyama
Organization	Kaiyu Clinic
Division name	Kaiyu Clinic
Address	3-3-6 Sagimiya, Nakano-ku, Tokyo
TEL	03-5356-6450
Email	abe@kaiyuclinic.com

Public contact
Name of contact person	Shigeru Imai
Organization	CROee Inc.
Division name	Evidence Division
Address	1-13-23 Minami-Ikebukuro, Toshima-ku, Tokyo
TEL	03-5953-2108
Homepage URL
Email	imai@croee.com

Sponsor
Institute	USHIKOSHI RESEARCH INSTITUTE FOR PHYSIOLOGY CO.,LTD.
Institute
Department

Funding Source
Organization	USHIKOSHI RESEARCH INSTITUTE FOR PHYSIOLOGY CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	カイユウ診療所（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 24 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 06 Month 01 Day
Anticipated trial start date	2015 Year 06 Month 26 Day
Last follow-up date	2015 Year 08 Month 05 Day
Date of closure to data entry	2015 Year 08 Month 26 Day
Date trial data considered complete	2015 Year 08 Month 26 Day
Date analysis concluded	2015 Year 12 Month 25 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 05 Day
Last modified on	2018 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020590